Rational treatment selection for Merkel Cell Carcinoma (MCC)

ISRCTN ISRCTN16290169
DOI https://doi.org/10.1186/ISRCTN16290169
Secondary identifying numbers 20444
Submission date
09/03/2016
Registration date
09/03/2016
Last edited
10/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-improving-usual-treatment-newly-diagnosed-merkel-cell-cancer-rational-compare-trial-rational-review-study

Contact information

Dr Rachel Blundred
Public

University of Birmingham
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone +44 121 414 3792
Email rationalmcc@trials.bham.ac.uk

Study information

Study designMulti-centre phase III randomised parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRational treatment selection for Merkel Cell Carcinoma (MCC): A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC with an observational study for patients ineligible for the randomised trial.
Study hypothesisThe aim of this study is to determine if radical surgery or radical radiotherapy as first definitive treatment
for the primary merkel cell carcinoma (MCC) results in better control of loco-regional disease.
Ethics approval(s)15/WM/0454
ConditionMerkel cell carcinoma
InterventionParticipants are randomised to one of two study arms.

Arm A - Prioritise surgery: WLE of the primary site with radiotherapy reserved for later adjuvant treatment in selected patients.
Arm B - Prioritise radiotherapy: Early use of radical radiotherapy to the primary site without prior radical surgery.
Intervention typeProcedure/Surgery
Primary outcome measureTime from randomisation to loco-regional treatment failure is determined from data collected throughout the study and up to 2 years of follow-up.
Secondary outcome measures1. Progression free survival
2. Proportion of patients alive and free of disease
3. Quality of Life is measured at baseline, 3, 6, 9, 12 and 24 months from randomisation;
4. Survival
5. Time to distant progression
6. Time to local failure
7. Time to regional nodal failure
Overall study start date31/03/2016
Overall study end date30/09/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 400; UK Sample Size: 400
Participant inclusion criteriaGeneral inclusion criteria for all patients:
1. Patients newly diagnosed with histologically-proven MCC (either primary and/or regional nodal disease)
2. Completion of clinical and radiological staging investigations, including CT imaging (or other modality) of regional nodal basin(s) and major viscera (and SLNB if clinically appropriate) to identify regional and distant metastases
3. No distant metastases beyond the regional nodal basin (i.e. not stage IV disease)
4. Being considered for radical treatment to achieve long term disease control
5. Able to give valid informed consent
6. Consent for collection of data and tissue samples and follow up.
7. Life expectancy six months or greater in relation to general fitness and co-morbidities

Additional inclusion criteria for rational compare:
1. Patients newly diagnosed with histologically-proven primary MCC
2. In the opinion of the SSMDT, the primary MCC can be encompassed both within a wide surgical margin and within a radiotherapy field, and the SSMDT is in equipoise regarding WLE or radiotherapy as first treatment
3. Consent for randomisation into Rational Compare
Participant exclusion criteriaExclusion criteria for rational compare only:
1. The primary MCC has already been treated radically with WLE (surgical margins >10 mm) or RT
2. Intended use of regional or systemic chemotherapy (including molecularly targeted agents and immunotherapy)
Recruitment start date31/03/2016
Recruitment end date30/12/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Birmingham
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham
Hospital/treatment centre

Cancer Research UK Clinical Trials Unit
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

Research council

Medical Research Council
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date14/03/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 4.0 11/01/2019 10/10/2022 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN16290169_Protocol_v4.0_11Jan2019.pdf

Editorial Notes

10/10/2022: Protocol file uploaded.
09/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/03/2021 to 30/12/2018.
2. The overall end date was changed from 30/03/2021 to 30/09/2020.
3. The intention to publish date was changed from 30/03/2022 to 14/03/2022.
4. The publication and dissemination plan was added.
5. The participant level data sharing plan was added.
09/07/2020: The trial contact details have been made publicly visible.
02/04/2019: The condition has been changed from "Topic: Cancer; Subtopic: Cancer (Melanoma); Disease: Cancer (Melanoma)" to "Merkel cell carcinoma" following a request from the NIHR.
01/11/2017: Internal review.
28/10/2016: Cancer Help UK lay summary link added.